ID

39754

Description

Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response; ODM derived from: https://clinicaltrials.gov/show/NCT01128803

Link

https://clinicaltrials.gov/show/NCT01128803

Keywords

Versions (1)
  1. 2/16/20 2/16/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 16, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01128803

English

Eligibility Hepatocellular Carcinoma NCT01128803

1 forms  
Criteria
Description

Criteria

adults (men or women) aged between 18 and 80 years
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
patients affiliated to a social security reimbursement system
Description

Patients Affiliated Social security system

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C2371809
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
hepatocellular carcinoma
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
at least one dosage with alpha-foeto-protein ≥ 40 ng/ml
Description

Alpha one fetoprotein measurement Dosage Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0201539
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
patient already treated with chemoembolization, percutaneous destruction (alcohol or radiofrequency), surgery or sorafenib.
Description

Chemoembolization | Destruction Percutaneous | Radiofrequency destruction | Operative Surgical Procedures | sorafenib

Data type

boolean

Alias
UMLS CUI [1]
C0796679
UMLS CUI [2,1]
C1261381
UMLS CUI [2,2]
C0522523
UMLS CUI [3]
C0441517
UMLS CUI [4]
C0543467
UMLS CUI [5]
C1516119
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
negative test for pregnancy or effective contraception
Description

Pregnancy test negative | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
patient hiv-, hep b-, hep c-, htlv1 and 2-, syphilis-
Description

HIV | Hepatitis B | Hepatitis C | Human T-lymphotropic virus 1 | Human T-lymphotropic virus 2 | Syphilis

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0020094
UMLS CUI [5]
C0020099
UMLS CUI [6]
C0039128
hla a 0201 group
Description

HLA-A*02:01 antigen Group

Data type

boolean

Alias
UMLS CUI [1,1]
C1097566
UMLS CUI [1,2]
C0441833
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy < 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
pregnancy or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe auto-immune disease
Description

Autoimmune Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0205082
another malignant tumor except if considered as cured since more than 5 years
Description

Cancer Other | Exception Malignant Neoplasm Cured Duration

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C1880198
UMLS CUI [2,4]
C0449238
history of uncontrolled psychiatric condition
Description

Mental disorders Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
risk factors of creutzfeldt jacobs disease
Description

Risk factors Creutzfeldt-Jakob disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0022336
decompensated cirrhosis(ascites or child-pugh score greater than 8)
Description

Decompensated cirrhosis of liver | Ascites | Child-Pugh - Total Score

Data type

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C0003962
UMLS CUI [3]
C4055253
hepatic transplantation
Description

Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1]
C0023911
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Similar models

Eligibility Hepatocellular Carcinoma NCT01128803

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adult | Age
Item
adults (men or women) aged between 18 and 80 years
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Patients Affiliated Social security system
Item
patients affiliated to a social security reimbursement system
boolean
C0030705 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C2371809 (UMLS CUI [1,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Alpha one fetoprotein measurement Dosage Quantity
Item
at least one dosage with alpha-foeto-protein ≥ 40 ng/ml
boolean
C0201539 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Chemoembolization | Destruction Percutaneous | Radiofrequency destruction | Operative Surgical Procedures | sorafenib
Item
patient already treated with chemoembolization, percutaneous destruction (alcohol or radiofrequency), surgery or sorafenib.
boolean
C0796679 (UMLS CUI [1])
C1261381 (UMLS CUI [2,1])
C0522523 (UMLS CUI [2,2])
C0441517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C1516119 (UMLS CUI [5])
Item Group
C1512693 (UMLS CUI)
Pregnancy test negative | Contraceptive methods
Item
negative test for pregnancy or effective contraception
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
HIV | Hepatitis B | Hepatitis C | Human T-lymphotropic virus 1 | Human T-lymphotropic virus 2 | Syphilis
Item
patient hiv-, hep b-, hep c-, htlv1 and 2-, syphilis-
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0020094 (UMLS CUI [4])
C0020099 (UMLS CUI [5])
C0039128 (UMLS CUI [6])
HLA-A*02:01 antigen Group
Item
hla a 0201 group
boolean
C1097566 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
life expectancy < 3 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Autoimmune Disease Severe
Item
severe auto-immune disease
boolean
C0004364 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cancer Other | Exception Malignant Neoplasm Cured Duration
Item
another malignant tumor except if considered as cured since more than 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
Mental disorders Uncontrolled
Item
history of uncontrolled psychiatric condition
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Risk factors Creutzfeldt-Jakob disease
Item
risk factors of creutzfeldt jacobs disease
boolean
C0035648 (UMLS CUI [1,1])
C0022336 (UMLS CUI [1,2])
Decompensated cirrhosis of liver | Ascites | Child-Pugh - Total Score
Item
decompensated cirrhosis(ascites or child-pugh score greater than 8)
boolean
C1619727 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C4055253 (UMLS CUI [3])
Transplantation of liver
Item
hepatic transplantation
boolean
C0023911 (UMLS CUI [1])
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